Principal Device Quality Engineer - Global Biologics Operations
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life., Our North America Commercial Headquarters are in Wilmington, DE, and one of our three core global R&D centers is in Gaithersburg, MD. Gaithersburg is also home to MedImmune, the global biologics research and development arm of AstraZeneca. We have a number of other R&D, manufacturing and office locations across the country. As the Principal Device Engineer in Gaithersburg, MD, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. You will provide technical quality leadership and support for Gaithersburg medical device and combination products. This role will partner with internal and external partners for product development efforts to ensure product design history and risk management files are in accordance with FDA 21 CFR requirements and international standards. The Principal Device Engineer will be responsible to lead quality planning and risk management activities, as well as to provide sustaining engineering support through post-market surveillance, design changes, etc. The Principal Device Quality Engineer will be the Device Site Champion and will lead efforts at the site to transform Gaithersburg into a Center of Excellence in Combination Products and Medical Devices. Main Responsibilities: * Lead medical device and combination product Quality System initiatives at Gaithersburg. Develop strategies, priorities, and plans as required. * Support activities related to the Combination Product and Medical Device Quality Management System ensuring compliance to all applicable regulations. * Authoring, compilation and maintenance of Design History File content, Conformity Assessments, and Design Verification Plans * Co-Author technical specifications, design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer) * Support actions required as a result of updates to standards and/or new applicable standards. * Verification Plans and DHF creation/maintenance (including DMR), conformity assessments and risk management documentation * Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs. * Provide quality engineering support for the handling and trending of device design related complaint records. * Provide quality guidance in the handling of non-conformance and CAPAs related to the medical device development process. * Provide quality and technical support for the evaluation of change assessments for the combination product Quality system. * Interface with suppliers to address development, risk management, change control, quality or auditing activities. * Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. * Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. * Lead design control gap assessments, remediation planning, and remediation execution as required. * Support the New Product Introduction (eg Pre-filled Syringes, Auto injectors, etc). * BS and/or MS in engineering or equivalent technical discipline * Five (5) years or more of experience supporting Quality Engineering of Combination Products and Devices * Extensive knowledge of global Quality System requirements (specifically 21 CFR Parts 4, 210, 211, 803, 806, & 820, and ISO 13485) required * Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required Desirable Requirements: * Experience with Health Authority interactions * Ability to lead efforts at the site and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP Device and Combination Product compliance.